Baxter begins phase 2 adult stem cell trial in patients with coronary artery disease

By Lisa Kerner

Erie, Pa., March 7 - Baxter Healthcare Corp. said it has started the first human phase 2 adult stem cell therapy trial in the United States designed to investigate the efficacy, tolerability and safety of blood-derived selected CD34+ stem cells in patients with chronic myocardial ischemia (CMI), a severe form of coronary artery disease.

In CMI, coronary arteries narrow, resulting in limited blood flow to the heart. The condition affects hundreds of thousands of new patients each year, according to a company news release.

Baxter's prospective, randomized, double-blind, placebo-controlled, multi-center study will include about 150 adult patients who are on maximal medical therapy but not suitable candidates for conventional procedures to improve blood flow to the heart, such as angioplasty, stents or coronary artery bypass surgery, the company said.

Once a baseline frequency and severity of CMI for all study participants is established, patients will be randomly selected to receive either one of two dosing levels of CD34+ stem cells, or a placebo. Researchers will conduct follow-up examinations with the patients for 12 months, Baxter said.

"Ultimately, our goal with this study is to advance the medical community's scientific understanding of the potential for autologous CD34+ cells to provide safe and effective outcomes for patients with a serious form of heart disease," Baxter chief scientific officer Norbert Riedel said in the release.

In a similar phase 1 trial being conducted in Boston, preliminary anecdotal patient reports indicate that 16 or the 24 study participants reported feeling better with reductions in chest pain and improved exercise capacity during the early stage of the trial.

These initial results led directly to Baxter's decision to sponsor the phase 2 trial, the release stated.

Baxter Healthcare Corp., located in Deerfield, Ill., is the principal U.S. operating subsidiary of Baxter International Inc., which assists health care professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma.

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